Regulatory: Pharma

Dossier Preparation and Submission (NDA/BLA/MAA, IND/CTA)

Explore

FDA Application Preparation, Management, Publishing and Submission

EMA and EU Member States National Health Authorities Applications Preparation, Management, Publishing and Submission

Our Services: FDA Application

Preparation, Management, Publishing and Submission As part of our regulatory services, the Alira Health team can:

Prepare and submit IND, NDA, BLA, supplemental NDA/BLA for both 505(b)(1) and 505(b)(2) pathways in addition to ANDA applications.
Serve as the project manager for regulatory submissions, and plan, track, collect, review, and finalize the documents required as per the eCTD guidelines.
Act as a U.S. agent for FDA Submissions for companies located outside the U.S.

Our Services: EMA and EU Member States National Health Authorities Applications

Preparation, Management, Publishing and Submission As part of our regulatory services, the Alira Health team can liaise with health authorities and also prepare and submit:

Marketing Authorization Application (Centralized, Decentralized, National and Mutual Recognition Procedures).
Serve as the project manager for regulatory submissions, and plan, track, collect, review, and finalize the documents required as per the eCTD guidelines.
Clinical Trials Application (CTAs).
Variations (Type IA, IB and II) and renewals.

Regulatory: Pharma

Dossier Preparation and Submission (NDA/BLA/MAA, IND/CTA)

Explore

Our Services: FDA Application

Our Services: EMA and EU Member States National Health Authorities Applications

Contact us to learn more about how we can support your needs